MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER/COOLER 3T 110V/60 HZ; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-85

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united states.A livanova field service representative was dispatched to the facility to investigate the device and was able to duplicater ee 07 issue: the patient stirrer motor was seized.The patient stirrer motor was replaced and subsequent functional verification testing was completed without further issues and the unit was returned to service.Recommended to disinfect this system prior to patient use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed on patient side the error message pump 1 is blocked (error 7) while turning the device on.There was no patient involvement.

Event Description

See intial report.

Manufacturer Narrative

Based on device history review it can be highlighted that device was installed since 2019 and no other similar event occurred.It cannot be ruled out that the stirrer motor block was due to advanced corrosion process inside the ball bearing.The causes leading to the corrosion, which generates irregularities on the surface of the balls, are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: HEATER/COOLER 3T 110V/60 HZ
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18739017
• MDR Text Key: 335755293
• Report Number: 9611109-2024-00085
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1